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AboutUnmet NeedCommunity-acquired PneumoniaComplicated Skin & Soft Tissue InfectionsMode of ActionVideoCommunity-acquired PneumoniaComplicated Skin & Soft Tissue InfectionsPatient ProfilesProfiles of Patients With CAPIdentify ZINFORO® Patient With CAPProfiles of Patients With cSSTIIdentify ZINFORO® Patient With cSSTIDosingRecommended Dosing ScheduleSimple DosingRenal AdjustmentEfficacyCommunity-acquired PneumoniaClinical Efficacy: Proven Clinical EfficacyClinical Efficacy: Evidence of Rapid ResponsePivotal Clinical StudiesMicrobiology: Optimising OutcomesMicrobiology: CoverageMicrobiology: Low MIC ValuesComplicated Skin & Soft Tissue InfectionsClinical Efficacy: Proven Clinical EfficacyClinical Efficacy: Evidence of Rapid ResponsePivotal Clinical StudiesMicrobiology: Optimising OutcomesMicrobiology: CoverageMicrobiology: Low MIC ValuesSafetySafetyKey safety featuresLow Incidence of Discontinuation in CAPLow Incidence of Discontinuation in cSSTIClinical & Scientific Data Clinical & Scientific Data Efficacy in the Treatment of CAPClinical Cure Rates Against Relevant PathogensClinical Cure Rates Across Patient SubgroupsDemonstrated Superiority to CeftriaxoneEarly Clinical ResponseReal-world Efficacy in Elderly PatientsConsistent Clinical Cure Rates in cSSTIClinical Cure Rates in Common Causative PathogensClinical Cure Rates in Patients With ComorbiditiesEarly Clinical EfficacyReal-life Efficacy in Clinical PracticeSupport & ResourcesSupport & ResourcesClinical updatesPrescribing InformationVideosWebinars

Pivotal Clinical Studies

Pivotal Phase III ZINFORO® (ceftaroline fosamil) CAP studies
 

The efficacy and tolerability of ZINFORO® (ceftaroline fosamil) monotherapy have been consistently demonstrated in 6 large, double-blind, Phase III, randomised controlled clinical trials: 3 involving adult patients with cSSTI and 3 involving patients with CAP.1-4

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Primary end point outcomes1

Clinical cure rates: FOCUS 1 and FOCUS 2
ZINFORO® (ceftaroline fosamil) 600 mg q12h demonstrated comparable efficacy versus ceftriaxone
1 g q24h in terms of clinical cure rates.

 


Primary end point outcomes2

Clinical cure rates: Asia CAP
ZINFORO® (ceftaroline fosamil) 600 mg q12h demonstrated superior efficacy versus ceftriaxone 2 g q24h in terms of clinical cure rates.

​​​​​​​Non-inferiority was defined as a lower limit of the 95% CI ≥–10% for the between-group difference. If this was achieved, the protocol stated that superiority would be concluded if the lower limit of the 95% CI ≥0%.2 The safety profile of ZINFORO® (ceftaroline fosamil) was similar to that observed in the pooled Phase III CAP and cSSTI studies.2


​​​​​​​CAP, community-acquired pneumonia; CE, clinically evaluable; CI, confidence interval; cSSTI, complicated skin and soft tissue infection; EOT, end of treatment; FOCUS, ceFtarOline Community-acquired pneUmonia trial vS ceftriaxone in hospitalized patients; ITT, intent-to-treat; IV, intravenous; LFU, late follow-up; ME, microbiologically evaluable; MITT, modified intent-to-treat; MITTE, modified intent-to-treat efficacy; mMITT, microbiologically modified intent-to-treat; PORT, Pneumonia Patient Outcomes Research Team; q12h, every 12 hours; q24h, every 24 hourly TOC, test-of-cure.
​​​​​​​

References:

File TM Jr, Low DE, Eckburg PB, et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia [published correction appears in Clin Infect Dis. 2011 Apr 1;52(7):967]. Clin Infect Dis. 2010;51(suppl 12):1395-1405.Zhong NS, Sun T, Zhuo C, et al. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis. 2015;15(suppl 2):161-171.Corey GR, Wilcox M, Talbot GH, et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010;51(suppl 6):641-650.Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016;71(suppl 12):3575-3584.


​​​​​Please click the Prescribing Information link to view the safety and adverse events information of ZINFORO®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
​​​​​​​
PP-ZFO-IND-0417 June 2022

Community-acquired Pneumonia
About

Fifth-generation cephalosporin with broad coverage

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Dosing

Simple dosing with a flexible infusion time

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Safety

Safety profile consistent with other cephalosporins

Review safety profile


Clinical & Scientific Data

​​​​ZINFORO® in the treatment of CAP and cSSTI​​​​​​

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